LPULSA SYL-9000 OPHTHALMIC YAG LASER

K990075 · Light-Med(Usa), Inc. · HQF · Mar 30, 1999 · Ophthalmic

Device Facts

• Record ID: K990075
• Device Name: LPULSA SYL-9000 OPHTHALMIC YAG LASER
• Applicant: Light-Med(Usa), Inc.
• Product Code: HQF · Ophthalmic
• Decision Date: Mar 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Posterior Capsulotomy Pupillary Membranectomy

Device Story

LPULSA SYL-9000 is an ophthalmic YAG laser used by ophthalmologists in clinical settings. Device delivers focused laser energy to ocular tissues to perform posterior capsulotomy and pupillary membranectomy. System operates via standard YAG laser photodisruption principles to create openings in posterior capsule or pupillary membranes. Physician controls laser parameters and delivery via slit-lamp interface. Output facilitates non-invasive ocular surgery, reducing need for traditional surgical intervention and improving patient visual outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

Ophthalmic YAG laser system; utilizes photodisruption principle for ocular tissue ablation. Form factor is a slit-lamp integrated laser system. Energy source is a YAG laser. Device is intended for professional use in clinical environments.

Indications for Use

Indicated for patients requiring posterior capsulotomy or pupillary membranectomy procedures.

Regulatory Classification

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 1999

Mr. Thomas V. Keeley Light-Med (USA), Inc. 110P Via Estrada Laguna Hills, California 92653

Re: K990075 Trade Name: LPULSA SYL-9000 Ophthalmic YAG Laser Regulatory Class: II Product Code: HQF Dated: January 5, 1999 Received: January 11, 1999

Dear Mr. Keeley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Thomas V. Keeley

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for use

Center for Devices and Radiological Health

K990075 510(k) Number (if known):

Device Name:

LPULSA SYL-9000 Ophthalmic YAG Laser

Indications for Use:

Posterior Capsulotomy Pupillary Membranectomy

(do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter-Use
(Optional Format 1-2-9)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number ¥990075

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